St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)

Last updated: September 25, 2007
Sponsor: National Center for Complementary and Integrative Health (NCCIH)
Overall Status: Completed

Phase

2/3

Condition

Mood Disorders

Panic Disorders

Anxiety Disorders

Treatment

N/A

Clinical Study ID

NCT00118833
K23AT000583-01
  • Ages > 18
  • All Genders

Study Summary

This study will determine whether the herbal product St. John's wort is safe and effective in treating generalized social anxiety disorder (GSAD).

Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD than placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of GSAD

  • Brief Social Phobia Scale (BSPS) score of 20 or higher

Exclusion

Exclusion Criteria:

  • Comorbid anxiety, depressive, or bipolar disorders

  • Schizophrenia

  • Cognitive impairment

  • Substance abuse or dependence within 1 year prior to study entry

  • Any unstable medical condition

  • Clinically significant laboratory or electrocardiogram (EKG) abnormality

  • Currently use psychotropic medications or may need psychotropic medication during thestudy

  • Psychotherapy within 6 weeks prior to study entry

  • Failed a previous trial of St. John's wort at doses of 1800 mg/day or greater

  • Pregnancy or breastfeeding

Study Design

Total Participants: 56
Study Start date:
August 01, 2002
Estimated Completion Date:
June 30, 2006

Study Description

The use of complementary and alternative medicine (CAM) has grown dramatically over the last decade. Botanical treatments originating from plants have become especially popular for treating conditions such as anxiety and depression. Evidence suggests that the botanical St. John's wort has neurochemical activity similar to that of conventional medications. However, research on the safety and effectiveness of St. John's wort is limited. This study will determine the safety and effectiveness of St. John's wort in treating GSAD, a serious condition characterized by intense fear of various social situations that may cause embarrassment.

Participants will be randomly assigned to receive either St. John's wort or placebo daily for 10 weeks. Self-report scales will be used to assess participants' GSAD symptoms at study entry and at study completion. Blood collection will occur at every weekly study visit to determine the levels of St. John's wort in the blood.

Connect with a study center

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

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